The 2.25ml COP (cyclic olefin polymer) SIN (staked in needle) will begin production in September 2019.
Gerresheimer is expanding its range of pre-fillable polymer syringes to include a new product: the Gx RTF® ClearJect® polymer needle syringe, 2.25ml. Like the 1.0ml syringe, production of the syringe will take place in Pfreimd, Germany.
The material used for the syringe is a high-performance polymer called COP (cyclic olefin polymer). It is suitable for use as primary packaging for sophisticated medications, especially for sensitive, biologicals, biosimilars, and biobetters. The product is developed in close cooperation between two Gerresheimer locations to create synergy between the syringe experts in Bünde and the plastic experts in Wackersdorf, Germany.
The Gx RTF ClearJect COP SIN of Gerresheimer Bünde GmbH is now available in the sizes 1.0ml long and 2.25 ml. The inspiration for the design comes from ISO 11040-6 and is registered. The syringe comes with a 27-gauge, 1/2-inch (12.7mm), thin-walled stainless-steel needle with three bevels.
Low Interaction Potential of the Syringe with Medication
COP does not release tungsten metal ions into the medication solution as glass syringes can, which is a concern for some. Since the entire syringe, including the insert-moulded needle, is produced in a single step, the product becomes free of tungsten and adhesives. The material has a high pH tolerance and the pH value does not change while in storage. The oxygen permeation rate is low in comparison to other plastics and the values for extractables and leachables are low.
Safety and Reliable Functionality for the End-User
Another important argument in favour of the Gx RTF ClearJect needle syringe is its end-user safety. COP is particularly break-resistant, making it suitable for packaging aggressive or toxic materials. The syringes are siliconized with a precisely controlled quantity of the highly viscous Dow Corning 360 MD (12,500 cST) silicone oil, to ensure reliable syringe functionality with low breakaway and sliding forces with the lowest possible particle load.
Precision and Flexible Design
Production in the injection moulding process ensures precise dimensions. The dead volume in the syringe is also minimized, reducing overall waste of the costly drugs. The material enables a broad range of design options, which make it ideal for customer specific-requirements. The syringes are also engineered for use in auto-injectors thanks to their robustness and precision.
The new Gx RTF ClearJect polymer syringe is packed in nests for easy handling and filling. These nests are suitable for all usual filling systems
Economic Efficiency Through Standard Components
This syringe system, like the 1.0ml syringe, is economical because of its innovative COP syringe body, which is designed to use commercially available standard components. Standard cannulas are used, as well as piston rods, piston plungers, backstops and closure systems.
Gerresheimer is a leading global partner to the pharma and healthcare industry. With speciality glass and plastic products, the Company contributes to health and well-being. Gerresheimer operates worldwide and its approximately 10,000 employees manufacture products in local markets, close to its customers.
With sites in Europe, the Americas and Asia, Gerresheimer generates revenues of around €1.4bn. The comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, micro pumps, pre-fillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines, with closure and safety systems, as well as packaging for the cosmetics industry.
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